Parkinson DiseaseNCT05919771
Effects of Rock Climbing on Parkinson's Disease
An observational study of Parkinson Disease, run by Marymount University at 1 site in United States.
Trial summary
This research study is being conducted to understand the outcomes of participation in the Up ENDing Parkinson's rock climbing program (24 sessions, or twice per week for about 12 weeks) on walking \& mobility, hand strength \& dexterity, and psychological well-being in individuals with Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- rock climbing
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to 12 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over the age of 18 with mild-to moderate idiopathic Parkinson's disease
Who may be able to join
- at least 18 years old
- Diagnosis of Parkinson's disease
- Hoehn \& Yahr score 1-3
- able to speak and read in English;
- able to ambulate at least 10 meters with no assistive device or human assistance
Who cannot join
- neurological disease diagnosis other than PD;
- uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated;
- cognitive or psychiatric impairment precluding informed consent or ability to following instructions;
- pregnancy;
- inability to ambulate 10 meters without assistive device or human assistance
Trial locations and contacts
1 site in 1 country.
About this study
This research study is being conducted to understand the outcomes of participation in the Up ENDing Parkinson's rock climbing program (24 sessions, or twice per week for about 12 weeks) on walking \& mobility, hand strength \& dexterity, and psychological well-being in individuals with Parkinson's Disease (PD). The rock climbing sessions are administered and supervised by Up ENDing Parkinson's, and are tailored to the skill level of the participant. Participants will answer questionnaires and complete physical performance tests twice, first prior to beginning the sessions and then again after the 24 sessions have been completed.
Read the detailed description
Parkinson's disease (PD) compromises multiple systems (neurological, musculoskeletal, cardiopulmonary, cognitive) over time, leading to functional decline. Additionally, individuals with PD may experience stressors commonly associated with chronic illness that can negatively impact psychological well-being. Exercise is commonly prescribed for individuals with PD and recently, interventions that are vigorous in nature and community- and performance-based are gaining traction (e.g., dancing, boxing, rock climbing). Despite increasing popularity, the evidence-base for these programs is still developing and far from conclusive. Recommendations are strong for: Community-based exercise, intensive aerobic and resistance training, and external cueing (Osborne et al., 2022). Rock climbing (RC) contains each of these elements and could potentially be a therapeutic intervention for people with PD. Yet little is known about the outcomes of this particular form of organized physical activity programs for this health condition. One such program is the rock climbing experiences offered by the UpENDing Parkinson's Rock Climbing (UEPRC).
The specific aims of this study are to characterize the effects of UEPRC on: 1) mobility and walking; 2) upper extremity (UE) functioning and 3) psychological and social well-being.
Participants will complete 24 rock climbing sessions tailored to their skill levels supervised by UEPRC over approximately 12 weeks.
- Conditions
- Parkinson Disease
- Being tested
- rock climbing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rock climbingOther
Vertical ascent of a surface specifically designed to elicit the skills that might be required to scale a naturally occurring rock formation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Community Mobility and Ambulation
Test of specific tasks to be accomplished to walk forward on a level surface safely and efficiently as evidence by the Community Balance and Mobility Scale (CBMS). CBMS is scored from 0-96 with higher scores denoting better performance.
Measured: Baseline and at 12 weeks
Secondary outcomes (6)
Change in Agility
Test of the ability to move forward, laterally, and backward on a level surface safely and efficiently as evidence by the Agility T-Test.
Measured: Baseline and at 12 weeks
Change in Dexterity
This test assesses upper extremity dexterity by assessing the time it takes to remove 9 pegs from a tray and place in peg holes and then remove pegs and place them back in tray as measured by the 9-Hole Peg Test.
Measured: Baseline and at 12 weeks
Change in Reaction Time
This test assesses combined cognitive and physical reaction time to initiate a movement response utilizing colored light stimuli as evidenced by using Blaze Pods.
Measured: Baseline and at 12 weeks
Change in Apathy
This survey addresses lack of emotion, interest, concern, or recognition of goals by measuring levels of participant's interest, motivation, and engagement as evidenced by the Starkstein Apathy Scale. The Starkstein Apathy Scale scores range from 0-42 with higher scores representing greater levels of apathy.
Measured: Baseline and at 12 weeks
Change in Resilience
This survey measures one's ability to thrive in the face of adversity as evidenced by the Connor-Davidson Resilience Scale 25 (CD-RISC-25). CD-RISC-25 scores range from 0-100 with higher scores indicating greater resilience.
Measured: Baseline and at 12 weeks
Change in Social Adaptation
This survey measures motivation and behavior as related to work and hobbies, family and relationships, and social situations as evidenced by the Social Adaptation Self-Evaluation Scale (SAS). SAS scores range from 0-63 with higher scores representing better social adaptation.
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start12 Jul 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marymount University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Ries, Marymount University
- Investigators
- Julie D Ries, PhD, Principal investigator, Marymount University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919771
- Sponsor's protocol ID
- 831
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.
PubMed 34963139
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rock Climbing on Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05919771
- Acronym / sponsor ID
- 831
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Marymount UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to understand the outcomes of participation in the Up ENDing Parkinson's rock climbing program (24 sessions, or twice per week for about 12 weeks) on walking \& mobility, hand strength \& dexterity, and psychological well-being in individuals with Parkinson's Disease (PD). The rock climbing sessions are administered and supervised by Up ENDing Parkinson's, and are tailored to the skill level of the participant. Participants will answer questionnaires and complete physical performance tests twice, first prior to beginning the sessions and then again after the 24 sessions have been completed.
Detailed description
Parkinson's disease (PD) compromises multiple systems (neurological, musculoskeletal, cardiopulmonary, cognitive) over time, leading to functional decline. Additionally, individuals with PD may experience stressors commonly associated with chronic illness that can negatively impact psychological well-being. Exercise is commonly prescribed for individuals with PD and recently, interventions that are vigorous in nature and community- and performance-based are gaining traction (e.g., dancing, boxing, rock climbing). Despite increasing popularity, the evidence-base for these programs is still developing and far from conclusive. Recommendations are strong for: Community-based exercise, intensive aerobic and resistance training, and external cueing (Osborne et al., 2022). Rock climbing (RC) contains each of these elements and could potentially be a therapeutic intervention for people with PD. Yet little is known about the outcomes of this particular form of organized physical activity programs for this health condition. One such program is the rock climbing experiences offered by the UpENDing Parkinson's Rock Climbing (UEPRC).
The specific aims of this study are to characterize the effects of UEPRC on: 1) mobility and walking; 2) upper extremity (UE) functioning and 3) psychological and social well-being.
Participants will complete 24 rock climbing sessions tailored to their skill levels supervised by UEPRC over approximately 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over the age of 18 with mild-to moderate idiopathic Parkinson's disease
Key inclusion criteria (5 listed)
- at least 18 years old
- Diagnosis of Parkinson's disease
- Hoehn \& Yahr score 1-3
- able to speak and read in English;
- able to ambulate at least 10 meters with no assistive device or human assistance
Key exclusion criteria (5 listed)
- neurological disease diagnosis other than PD;
- uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated;
- cognitive or psychiatric impairment precluding informed consent or ability to following instructions;
- pregnancy;
- inability to ambulate 10 meters without assistive device or human assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rock climbingVertical ascent of a surface specifically designed to elicit the skills that might be required to scale a naturally occurring rock formation | Other | – |
Primary outcome
Change in Community Mobility and Ambulation
Time frame: Baseline and at 12 weeks
Test of specific tasks to be accomplished to walk forward on a level surface safely and efficiently as evidence by the Community Balance and Mobility Scale (CBMS). CBMS is scored from 0-96 with higher scores denoting better performance.
6 secondary outcomes
Change in Agility
Time frame: Baseline and at 12 weeks
Change in Dexterity
Time frame: Baseline and at 12 weeks
Change in Reaction Time
Time frame: Baseline and at 12 weeks
Change in Apathy
Time frame: Baseline and at 12 weeks
Change in Resilience
Time frame: Baseline and at 12 weeks
Change in Social Adaptation
Time frame: Baseline and at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publication: PubMed 34963139Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie D Ries, PhD principal investigator
Marymount University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Marymount University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Community Mobility and Ambulation (time frame: Baseline and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.